Table 2.
Adverse Events Occurring in ≥10% of Patients During 1-Month NV1020 Administration Phase by Dose Levela
| |
NV1020 dose level (PFU) |
|||||
|---|---|---|---|---|---|---|
| |
Phase I |
Phase II |
OBD |
|||
| 3 × 106(n = 3) | 1 × 107(n = 3) | 3 × 107(n = 4) | 1 × 108(n = 3) | 1 × 108(n = 19) | 1 × 108(n = 22) | |
| Pyrexia | 3 (100%) | 2 (67%) | 4 (100%) | 100% | 18 (95%) | 21 (95%) |
| Chills | 3 (100%) | 0 (0%) | 2 (50%) | 2 (67%) | 11 (58%) | 13 (59%) |
| Nausea | 3 (100%) | 0 (0%) | 2 (50%) | 0 (0%) | 12 (63%) | 12 (55%) |
| Myalgia, pain at other sites | 1 (33%) | 1 (33%) | 1 (25%) | 0 (0%) | 11 (58%) | 11 (50%) |
| Headache | 0 (0%) | 1 (33%) | 2 (50%) | 1 (33%) | 10 (47%) | 11 (50%) |
| Fatigue | 0 (0%) | 1 (33%) | 1 (25%) | 1 (33%) | 7 (37%) | 8 (36%) |
| Vomiting | 1 (33%) | 0 (0%) | 2 (50%) | 1 (33%) | 7 (37%) | 8 (36%) |
| Abdominal pain | 0 (0%) | 1 (33%) | 1 (25%) | 0 (0%) | 5 (26%) | 5 (23%) |
| Diarrhea | 0 (0%) | 0 (0%) | 1 (25%) | 0 (0%) | 4 (21%) | 4 (18%) |
| Abdominal distention | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (16%) | 3 (14%) |
| Constipation | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (16%) | 3 (14%) |
| Hypotension | 1 (33%) | 0 (0%) | 0 (0%) | 0 (0%) | 3 (16%) | 3 (14%) |
a
The optimal biological dose (OBD) level comprises 3 patients from phase I and 19 from phase II.